Generic Kalydeco Availability

Last updated on Apr 10, 2025.

Kalydeco is a brand name of ivacaftor, approved by the FDA in the following formulation(s):

KALYDECO (ivacaftor - granule;oral)

Manufacturer: VERTEX PHARMS INC
Approval date: March 17, 2015
Strength(s): 50MG/PACKET ^[RLD], 75MG/PACKET ^[RLD]
Manufacturer: VERTEX PHARMS INC
Approval date: April 29, 2019
Strength(s): 25MG/PACKET ^[RLD]
Manufacturer: VERTEX PHARMS INC
Approval date: May 3, 2023
Strength(s): 5.8MG/PACKET ^[RLD], 13.4MG/PACKET ^[RLD]

KALYDECO (ivacaftor - tablet;oral)

Manufacturer: VERTEX PHARMS
Approval date: January 31, 2012
Strength(s): 150MG ^[RLD]

Is there a generic version of Kalydeco available?

No. There is currently no therapeutically equivalent version of Kalydeco available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kalydeco. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Pharmaceutical composition and administrations thereof
Patent 10,272,046
Issued: April 30, 2019
Inventor(s): Dokou Eleni & Jamzad Shahla & Caesar & Jr. John P. & Fawaz Majed & Das Laura & Gu Chong-Hui & Hurter Patricia Nell & Israni Meghna Jai & Johnston Meghan M. & Knezic Dragutin & Kuzmission Andrew G. & Wang HongRen
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Patent expiration dates:
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 10272046
  ✓
  Drug product
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 10272046
  ✓
  Drug product
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 10272046
  ✓
  Drug product
Pharmaceutical composition and administrations thereof
Patent 10,646,481
Issued: May 12, 2020
Inventor(s): Rowe William & Hurter Patricia & Young Christopher & Dinehart Kirk & Verwijs Marinus Jacobus & Overhoff Kirk & Grootenhuis Peter D. J. & Botfield Martyn & Grossi Alfredo
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Patent expiration dates:
- August 13, 2029
  ✓
  Drug product
Pharmaceutical composition and administrations thereof
Patent 10646481*PE
Issued: May 12, 2020
Inventor(s): Rowe; William et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Patent expiration dates:
- February 13, 2030
Pharmaceutical composition and administrations thereof
Patent 11,147,770
Issued: October 19, 2021
Inventor(s): Dokou Eleni & Jamzad Shahla & Caesar & Jr. John P. & Fawaz Majed & Das Laura & Gu Chong-Hui & Hurter Patricia Nell & Israni Meghna Jai & Johnston Meghan M. & Knezic Dragutin & Kuzmission Andrew G. & Wang Hongren
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Patent expiration dates:
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11147770
  ✓
  Drug product
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11147770
  ✓
  Drug product
Pharmaceutical composition and administrations thereof
Patent 11,564,916
Issued: January 31, 2023
Inventor(s): Rowe; William et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Patent expiration dates:
- August 13, 2029
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
- August 13, 2029
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
- August 13, 2029
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
Pharmaceutical composition and administrations thereof
Patent 11564916*PE
Issued: January 31, 2023
Inventor(s): Rowe; William et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Patent expiration dates:
- February 13, 2030
Pharmaceutical composition and administrations thereof
Patent 11,752,106
Issued: September 12, 2023
Inventor(s): Dokou; Eleni et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Patent expiration dates:
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <6 YEARS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11752106
  ✓
  Drug product
Pharmaceutical composition and administrations thereof
Patent 12,214,083
Issued: February 4, 2025
Inventor(s): Dokou; Eleni et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Patent expiration dates:
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS IN THE CFTR GENE AT LEAST ONE RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12214083
  ✓
  Drug product
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS IN THE CFTR GENE AT LEAST ONE RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12214083
  ✓
  Drug product
- February 27, 2033
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS IN THE CFTR GENE AT LEAST ONE RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12214083
  ✓
  Drug product
Modulators of ATP-binding cassette transporters
Patent 7,495,103
Issued: February 24, 2009
Inventor(s): Hadida-Ruah; Sara et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Cambridge, MA)
The present invention relates to modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- May 20, 2027
  ✓
  Drug substance
  ✓
  Drug product
Modulators of ATP-binding cassette transporters
Patent 7495103*PED
Issued: February 24, 2009
Inventor(s): Hadida-Ruah; Sara et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Cambridge, MA)
The present invention relates to modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- November 20, 2027
  ✓
  Pediatric exclusivity
Modulators of ATP-binding cassette transporters
Patent 8,324,242
Issued: December 4, 2012
Inventor(s): Ruah Sara Hadida & Hazlewood Anna & Grootenhuis Peter D. J. & Van Goor Fredrick & Singh Ashvani & Zhou Jinglan & McCartney Jason
Assignee(s): Vertex Pharmaceutical Incorporated
The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- August 5, 2027
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
- August 5, 2027
  ✓
  Patent use: METHOD OF TREATING CYSTIC FIBROSIS
- August 5, 2027
  ✓
  Patent use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, SUCH AS A PATIENT HAVING A G551D MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
- August 5, 2027
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
- August 5, 2027
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
Modulators of ATP-binding cassette transporters
Patent 8324242*PED
Issued: December 4, 2012
Inventor(s): Ruah; Sara Hadida et al.
Assignee(s): Vertex Pharmaceutical Incorporated (Cambridge, MA)
The present invention relates to modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- February 5, 2028
  ✓
  Pediatric exclusivity
Modulators of ATP-binding cassette transporters
Patent 8,354,427
Issued: January 15, 2013
Inventor(s): Van Goor Fredrick
Assignee(s): Vertex Pharmaceutical Incorporated
The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- July 6, 2026
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS A R117H MUTATION IN THE CFTR GENE
- July 6, 2026
  ✓
  Patent use: METHOD OF TREATING CYSTIC FIBROSIS
- July 6, 2026
  ✓
  Patent use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, THE PATIENT HAVING A R117H MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
- July 6, 2026
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS A R117H MUTATION IN THE CFTR GENE
- July 6, 2026
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS A R117H MUTATION IN THE CFTR GENE
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 8,410,274
Issued: April 2, 2013
Inventor(s): Hurter Patricia & Rowe William & Young Christopher Ryan & Costache Adriana & Connelly Patrick R. & Krawiec Mariusz & Gong Yuchuan & Feng Yushi & Trudeau Martin
Assignee(s): Vertex Pharmaceuticals
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- December 28, 2026
  ✓
  Drug product
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent 8410274*PED
Issued: April 2, 2013
Inventor(s): Hurter; Patricia et al.
Assignee(s): Vertex Pharmaceuticals (Cambridge, MA)
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Modulators of ATP-binding cassette transporters
Patent 8,629,162
Issued: January 14, 2014
Inventor(s): Hadida-Ruah Sara & Hazlewood Anna & Grootenhuis Peter D. J. & Van Goor Fredrick & Singh Ashvani & Zhou Jinglan & McCartney Jason
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- June 24, 2025
  ✓
  Patent use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
- June 24, 2025
  ✓
  Patent use: USE OF IVACAFTOR FOR TREATING CYSTIC FIBROSIS IN A PATIENT WITH A MILD TO MODERATE CF PHENOTYPE WITH AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
- June 24, 2025
  ✓
  Patent use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
- June 24, 2025
  ✓
  Patent use: TREATMENT OF A MODERATE MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 8,754,224
Issued: June 17, 2014
Inventor(s): Hurter Patricia & Rowe William & Young Christopher R. & Costache Adriana & Connelly Patrick R. & Krawlec Mariusz & Gong Yuchuan & Feng Yushi & Trudeau Martin
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- December 28, 2026
  ✓
  Drug substance
  ✓
  Drug product
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent 8754224*PED
Issued: June 17, 2014
Inventor(s): Hurter; Patricia et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Pharmaceutical composition and administrations thereof
Patent 8,883,206
Issued: November 11, 2014
Inventor(s): Dokou Eleni & Jamzad Shahla & Caesar & Jr. John P. & Fawaz Majed & Das Laura & Gu Chong-Hui & Hurter Patricia Nell & Israni Meghna Jai & Johnston Meghan M. & Knezic Dragutin & Kuzmission Andrew G. & Wang HongRen
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Patent expiration dates:
- February 27, 2033
  ✓
  Drug product
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 9,670,163
Issued: June 6, 2017
Inventor(s): Hurter Patricia & Rowe William & Young Christopher R. & Costache Adriana & Connelly Patrick R. & Krawiec Mariusz & Gong Yuchuan & Feng Yushi & Trudeau Martin
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
  ✓
  Drug product
- December 28, 2026
  ✓
  Patent use: METHOD OF TREATING CYSTIC FIBROSIS
  ✓
  Drug product
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
  ✓
  Drug product
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO < 6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
  ✓
  Drug product
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 9670163*PED
Issued: June 6, 2017
Inventor(s): Hurter; Patricia et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- August 15, 2025 - THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
- April 29, 2026 - TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 MONTHS TO LESS THAN 12 MONTHS WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
- May 3, 2026 - NEW PATIENT POPULATION
- December 21, 2027 - FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION
- May 3, 2030 - THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 1 MONTH TO LESS THAN 4 MONTHS OF AGE WHO HAVE AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA

More about Kalydeco (ivacaftor)

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Cystic Fibrosis

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill V 150 is Kalydeco 150 mg — Kalydeco 150 mg (V 150)